Akhmetzianov Rustem V, Bredikhin Roman A
Interregional Clinical Diagnostic Center, Department of Vascular Surgery, Kazan, Russia.
Kazan State Medical University, Department of Cardiovascular and Endovascular Surgery, Kazan, Russia.
Pain Ther. 2021 Dec;10(2):1567-1578. doi: 10.1007/s40122-021-00312-6. Epub 2021 Sep 19.
Pelvic congestion syndrome (PCS) may be effectively managed with conservative treatment in certain patients. Treatment with venoactive drugs is common, but supportive data are limited. This study evaluated the clinical efficacy of micronized purified flavonoid fraction (MPFF) in women with PCS.
In a single-blind, placebo-controlled study, women with duplex ultrasound diagnosis of pelvic varicose veins (PVV) and PCS were randomized to MPFF 1000 mg once daily or placebo for 2 months. Clinical manifestations of PCS were evaluated at baseline and end of treatment (M2) using three assessment tools: disease-specific quality of life (QoL) Pelvic Varicose Vein Questionnaire (PVVQ), Pelvic Venous Clinical Severity Score (PVCSS), and the Visual Analog Scale (VAS) for the main symptoms of the disease.
A total of 83 women were included, 42 received MPFF and 41 received placebo. In the MPFF group, the mean global PVVQ QoL index decreased significantly from 45.1 ± 14.7 at baseline to 36.6 ± 10.6 at M2 (mean change: 8.2 ± 10.4); no significant change was observed in the control group (mean change: - 0.3 ± 4.0). The between-group difference was statistically significant (P < 0.001). Compared with control, significant improvements were observed in all four QoL parameters (pain, physical, social, psychological, all P < 0.001). The mean PVCSS summary score decreased significantly by 3.4 ± 3.4 in the MPFF group (P < 0.001) compared with a non-significant change of - 0.2 ± 1.6 in the control group (between-group difference P < 0.001). In the MPFF group, improvements were statistically significant for 6 out of 10 clinical manifestations of PCS measured using the PVCSS, including pain (mean change from baseline: 0.5 ± 0.7) heaviness (0.4 ± 0.7), discomfort (0.6 ± 0.7) and tenderness (0.3 ± 0.5). No significant improvements were observed in the control group. When measured by VAS, between-group differences were statistically significant for the overall summary score (P < 0.001) and for 8 out of 10 PCS symptoms, including: pain (mean MPFF change from baseline: 2.0 ± 2.2), heaviness (1.3 ± 2.1), discomfort (1.5 ± 2.0), tenderness (0.9 ± 1.9), and edema (1.3 ± 2.1).
In women with PCS, conservative treatment with MPFF was associated with improved QoL and reduced symptom severity. MPFF may be considered an effective and safe treatment option for PCS in routine clinical practice.
盆腔充血综合征（PCS）在某些患者中可通过保守治疗得到有效管理。使用血管活性药物进行治疗很常见，但支持性数据有限。本研究评估了微粉化纯化黄酮类成分（MPFF）对患有PCS的女性的临床疗效。
在一项单盲、安慰剂对照研究中，经双功超声诊断为盆腔静脉曲张（PVV）和PCS的女性被随机分为两组，一组每天服用一次1000毫克MPFF，另一组服用安慰剂，为期2个月。使用三种评估工具在基线和治疗结束时（第2个月）对PCS的临床表现进行评估：疾病特异性生活质量（QoL）盆腔静脉曲张问卷（PVVQ）、盆腔静脉临床严重程度评分（PVCSS）以及针对该疾病主要症状的视觉模拟量表（VAS）。
总共纳入了83名女性，42名接受MPFF治疗，41名接受安慰剂治疗。在MPFF组中，PVVQ的总体生活质量指数平均值从基线时的45.1±14.7显著降至第2个月时的36.6±10.6（平均变化：8.2±10.4）；对照组未观察到显著变化（平均变化：-0.3±4.0）。组间差异具有统计学意义（P<0.001）。与对照组相比，在所有四个生活质量参数（疼痛、身体、社会、心理，所有P<0.001）方面均观察到显著改善。MPFF组的PVCSS总评分平均值显著下降了3.4±3.4（P<0.001），而对照组无显著变化，为-0.2±1.6（组间差异P<0.001）。在MPFF组中，使用PVCSS测量的PCS的10种临床表现中有6种改善具有统计学意义，包括疼痛（相对于基线的平均变化：0.5±0.7）、坠胀感（0.4±0.7）、不适感（0.6±0.7）和压痛（0.3±0.5）。对照组未观察到显著改善。通过VAS测量时，总体总评分的组间差异具有统计学意义（P<0.001），并且在PCS的10种症状中有8种具有统计学意义，包括：疼痛（MPFF相对于基线的平均变化：2.0±2.2）、坠胀感（1.3±2.1）、不适感（1.5±2.0）、压痛（0.9±1.9）和水肿（1.3±2.1）。
在患有PCS的女性中，MPFF保守治疗与生活质量改善和症状严重程度降低相关。在常规临床实践中，MPFF可被视为PCS的一种有效且安全的治疗选择。
